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NCT00127634 · ClinicalTrials.gov registry record · Phase 3

Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
385
Enrollment target
20
Study locations

NCT00127634 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Eli Lilly and Company. The registered enrollment target is 385 participants, below the 1,263-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00127634, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
385 participants
Enrollment target
20
Study locations

Study Summary

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Conditions Studied

Interventions

  • DRUG Insulin Glargine
  • DRUG Human Insulin Inhalation Powder
  • DRUG Injectable Insulin

Study Locations (20)

Florida

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Hollywood
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Jacksonville
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Largo
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - New Port Richey
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - West Palm Beach

California

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Sacramento
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Walnut Creek

Colorado

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Aurora
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Denver

Illinois

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Chicago
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Springfield

Delaware

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Newark

Georgia

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Atlanta

Idaho

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Idaho Falls

Indiana

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Indianapolis

Trial Details

FieldValue
Enrollment Target 385 participants
Start Date 2005-07
Est. Completion 2008-05
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT00127634

The ClinicalTrials.gov registry entry for NCT00127634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 385 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,263-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (70% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Insulin Glargine is the first listed.

NCT00127634 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT00127634 about?

NCT00127634 is a clinical study titled "Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes". This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

What is the current status of trial NCT00127634?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 385 participants. The study started on 2005-07. Estimated completion is 2008-05.

What conditions does trial NCT00127634 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.

What interventions are being tested in trial NCT00127634?

The interventions under investigation include: Insulin Glargine (DRUG), Human Insulin Inhalation Powder (DRUG), Injectable Insulin (DRUG).

Who is sponsoring clinical trial NCT00127634?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00127634 being conducted?

This trial has 20 study locations across California, Colorado, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Mellitus, Type 1

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.